In the U.S., a high number of potentially dangerous energy drinks and dietary supplements are regularly sold under comparatively weak dietary supplement rules (as opposed to the stricter standards that cover food additives and over-the-counter drugs). That means they reach consumers without proper safety checks, standardized dosage limits, or ingredient disclosure requirements.
This John Foy & Associates study will consider the rapid growth of the energy drink and dietary supplement industries, why so many dangerous drinks and supplements have flooded the market, and the negative health effects suffered by consumers. We’ll also look at why caffeine is a particular problem, compare what’s in some of the popular products, and look at what’s being done about a significant national issue.
Let’s first consider how a legal loophole has enabled the value of both the energy drink and dietary supplement industries to run into the tens of billions.
The Scope of The Problem
In 2024, the U.S. energy drink market was worth just under $27 billion and is projected to reach $38 billion by the early 2030s; meanwhile, the $69.3 billion dietary supplement industry is also expected to rise, to just over $131 billion.
Much of this expansion can be traced directly back to 1994’s Dietary Supplement Health and Education Act (DSHEA), which meant the FDA thereafter had to prove an ingredient was unsafe before it could be removed. The Act also meant there was limited scope for a proper premarket product safety review, and allowed potentially misleading third-party marketing campaigns.
The effect of this change has been hugely significant. When the DSHEA first passed, the U.S. marketplace featured roughly 4,000 dietary supplement products. Today, the FDA estimates that there are as many as 100,000, a 25-fold increase, during a period when insufficient safety monitoring infrastructure was in place.
Energy drink companies exploit this regulatory flexibility: identical caffeinated beverages can be classified as either ‘food’ or as a ‘dietary supplement,’ with neither category subject to a federal caffeine limit.
This is especially significant for adolescents, whose cardiovascular and neurological systems are still developing. Up to 50% of teens have said they consume energy drinks, while roughly a third of 12-17-year-olds say they drink them regularly. Among teens who consume caffeine, 22% do so via energy drinks, compared to drinkers of tea (32%), coffee (31%) and soda (73%).
Popular energy drinks include Red Bull (80mg of caffeine), Bang or Reign (300mg), Celsius (200mg per 12-ounce can) and Alani Nu (200mg per 12-ounce can). (To compare, 200mg is around twice the rate of caffeine consumed in a cup of brewed coffee and half the FDA’s suggested 400mg daily limit for healthy adults.)
And there’s growing evidence of harm. A 2025 case report described a healthy 24-year-old who suffered cardiac arrest shortly after an energy-drink binge, and who subsequently needed emergency treatment for a ‘widowmaker’ coronary lesion.
Additionally, a 2025 review linked the stimulants in energy drinks to potentially life-threatening arrhythmias and cardiac events. At a national level, emergency department visits due to caffeine-related problems more than doubled between 2017 and 2024 among both 11-14 and 15-18-year-olds, while in 2024 America’s Poison Centers recorded 2,609 energy-drink exposure calls involving people aged 19 and under.
Because 1994’s DSHEA effectively removed most of the FDA’s premarket authority, that enabled the supplement market to massively expand to where it is today. Yet it’s worth asking the question: what are the current supplement regulations?
Supplement Regulations
The FDA stipulates one caffeine limit, which is that cola-type conventional foods must not exceed 0.02% caffeine by volume (roughly 71mg per 12-ounce can).
However, this is a threshold limit for cola-based products, not a general beverage limit: when it comes to energy drinks, there’s no equivalent federal ceiling. And when an energy drink is classified as a dietary supplement, caffeine is defined as an “old dietary ingredient” that predates 1994. This subsequently allows manufacturers to include it without the need for a New Dietary Ingredient notification or GRAS review.
This is markedly different from how the European Union regulates such products. In Europe, any drink that features over 150mg of caffeine per liter must carry warnings that advise against use by children, pregnant or breastfeeding women, and must disclose its caffeine content.
U.S. classifications also differ when it comes to post-market reporting. Companies that sell dietary supplements must report any deaths, life-threatening events, hospitalizations, or significant disabilities to the FDA within 15 business days. They must also retain adverse-event records for six years. For conventional foods, there’s no obligation to provide equivalent records.
Between January 2004 and October 2012, the FDA received 166 adverse-event reports and notifications regarding 18 deaths that involved four major energy-drink brands: 5-Hour Energy (92 reports, 13 deaths), Monster (40 reports, 5 deaths), Red Bull (21 reports), and Rockstar (13 reports). At the time, these products were classified as supplements; that meant mandatory reporting rules highlighted those cases.
Since then, several manufacturers (including Monster Beverage) have shifted their products toward conventional-food classification. Industry reports link the change to a desire to avoid stricter supplement reporting and manufacturing requirements.
In short, some manufacturers now avoid the reporting framework that highlights adverse responses and deaths by changing their product’s regulatory classification. And there’s currently no federal law to prevent that maneuver.
The FDA can still respond if a problem emerges, with powers to remove supplements they deem pose an ‘imminent hazard’; they can also recall and seize products, and impose penalties. But such powers are reactive.
There’s no obligation for such products to undergo premarket safety testing, face independent review, or adhere to caffeine ceiling limits before they reach consumers.
Caffeine and Consumer Risk
The people who drink the most energy drinks increasingly overlap with the people most vulnerable to their effects, a factor that’s partly driven by deliberate marketing ploys. Caffeine content ranges from 80mg in Red Bull to 300mg in Bang or Reign, compared with about 100mg in an 8-ounce cup of coffee. Wellness-focused brands like Celsius and Alani Nu contain around 200mg of caffeine per can while aggressively targeting younger women.
While women represent 34% of energy drink consumers, they make up more than 60% of Celsius consumers (compared with a typical category range of 38%-42%). And 44% of 18-34-year-old women report drinking more energy drinks than they did during the previous year.
Alani Nu’s social-media audience is 92% female, numbers built around influencer-driven wellness marketing as opposed to the extreme-sports imagery often associated with energy drinks. Celsius reinforced that strategy by buying Alani Nu for $1.8 billion in February 2025.
The worry is that wellness-related marketing can suggest that a 200mg caffeine dose (combined with stimulants like taurine and guarana) is linked with clean living and self-care. The reality is that there’s a genuine underlying risk of cardiovascular consequences.
A June 2024 Mayo Clinic study that examined 144 sudden cardiac arrest survivors found that 7 (about 5%) had consumed an energy drink shortly before the event. (Nearly all were subject to an underlying genetic heart condition, and researchers emphasized that the risk remains small and that factors like sleep deprivation, dehydration, extreme dieting, and additional substances may also have been factors.)
A key related condition is hypertrophic cardiomyopathy. This is the leading cause of sudden cardiac death in people under the age of 30, with a prevalence estimated as high as 1 in 500 young adults. Sudden cardiac death occurs about 1.7 per 100,000 person-years among young people; for young athletes, the number is 2 per 100,000.
A third of sudden cardiac deaths in young people remain unexplained (even after autopsy), and many people are unaware they have a condition that makes using stimulants disproportionately dangerous.
Risk further increases when users combine energy drinks with other substances. Up to 44% of college students say they’ve mixed alcohol with energy drinks, while 9%-12% say they do so monthly or weekly.
Caffeine can make a user feel less drunk without reducing actual impairment, and regular users show higher rates of binge drinking, impaired driving, and alcohol-related injuries. Energy drinks are also frequently a factor in ER visits alongside alcohol, prescription medications, and other substances, potentially compounding cardiovascular and neurological problems.
The data continually emphasizes the extent to which cardiovascular issues are increasingly associated with the heavy use of energy drinks.
Documented Energy-Drink Risk
A July 2024 Journal of Pediatrics review found that cardiovascular problems represented 47.7% of documented adverse effects in young people. They included chest pain, tachycardia, hypertension, myocardial infarction, and cardiac arrest. The review also found that the U.S. is still the world’s least-regulated country regarding this issue, despite pediatric authorities campaigning against the consumption of caffeine by children and adolescents.
Individual cases further emphasize the seriousness of the situation. In May 2024, a major restaurant withdrew a lemonade drink that contained up to 390mg of caffeine per serving and settled a range of wrongful death lawsuits between October 2024 and mid- 2025, after it was linked to fatal cardiac incidents.
In October 2025, a 17-year-old cheerleader and student council president (with no known pre-existing cardiovascular condition) died due to cardiomyopathy medically attributed to excessive caffeine intake. According to the victim’s family, she regularly drank a wellness-branded energy drink that contained 200mg per can, twice the 100mg single-serving maximum amount recommended for adolescents.
In June 2026, her wrongful-death lawsuit survived a motion to dismiss, and a state attorney general opened a separate investigation focused on potentially deceptive product marketing.
The physiological risks associated with caffeine are well established. Consumed at a level of 250–500mg, caffeine can cause restlessness, nervousness, insomnia, and tremors.
Rapid caffeine consumption to a level above 1,200mg (which is the FDA’s estimated danger threshold) increases the risk of seizures and cardiovascular-related issues, including rapid or irregular heartbeat, reduced cardiac blood flow, vomiting, disorientation, and breathing difficulties. An estimated lethal dose for an average adult is about 150–200mg/kg, although for vulnerable individuals, fatalities have been recorded at doses as low as 57mg/kg.
What’s Being Done?
Although various measures to combat the problem have been discussed and proposed at both state and federal levels, as of August 2026, none has become law.
Over the past two years, at least five states have introduced bills that intend to restrict energy-drink sales to minors. Connecticut would prohibit sales to anyone under 16, require ID verification for each purchase, and impose fines of up to $200 for a second offense and $350 for repeat violations.
Delaware’s HB 394 bill would ban energy drink sales to anyone under 18 (including caffeinated dietary supplements), with a one-year implementation period and penalties of up to $100 per offense.
Maine intends to recategorize soft drinks that contain at least 80mg of caffeine per 8 fl oz, closing a potential technical loophole; Oklahoma and Massachusetts have proposed similar measures. All bills are at various points of the legislative process, and the relatively modest penalties involved will generally target individual retailers as opposed to manufacturers.
At the federal level, the Sarah Katz Caffeine Safety Act (H.R. 2511) was introduced on March 31, 2025. If passed, the bill would mandate the inclusion of caffeine-content labeling on foods and supplements, impose a ‘high caffeine’ warning on products that feature above 150mg, and classify products that feature over 10mg of undisclosed caffeine as misbranded.
The bill currently sits with the House Energy and Commerce Committee, with no hearing or vote scheduled. The chances of the bill being successful are low: independent legislative trackers estimate a 6% chance that the bill will clear committee, and a 2% chance that it will be enacted.
The FDA has added caffeine-labeling guidance to its 2026 regulatory priority list. Although there are no further details about such guidance being imposed, the addition suggests that the agency considers caffeine labeling an active regulatory issue.
Overall, while there’s now clear and substantial activity around the matter of tightening caffeine regulations, very little has changed.
It’s still the case that age restrictions, warning labels, disclosure requirements, and misbranding rules depend on legislative or regulatory action. Currently, the original 1994 regulatory framework remains largely unchanged.
Conclusion
The U.S. energy-drink market has expanded rapidly under a regulatory framework enabled by the 1994 DSHEA, which allows manufacturers broad flexibility, imposes no federal caffeine limits on energy drinks, and doesn’t require premarket safety testing.
Teen consumption of caffeine is widespread and is increasingly targeted at young women, while evidence links high caffeine exposure to cardiovascular events and a rising number of caffeine-related ER visits. Yet, as of August 2026, proposed state restrictions, the federal Sarah Katz Caffeine Safety Act, and FDA labeling proposals have not been enacted.
The central issue is not just that energy drinks feature high caffeine levels. It’s also true that a rapidly growing, heavily marketed industry is selling products (often to a young audience) that contain up to 300mg of caffeine per can without a federal caffeine limit, premarket safety checks, or mandatory labeling requirements.
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